Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 222-700-7 | CAS number: 3578-72-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: GLP-status not known, guideline not known, information from a peer-reviewed, published review article. Notable limitations in design and/or reporting, reliability not known.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate and zinc stearate
- Author:
- Cosmetics Ingredients Review
- Year:
- 1 982
- Bibliographic source:
- Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177
- Reference Type:
- publication
- Title:
- Percutaneous absorption of some anionic surfactants
- Author:
- Howes D
- Year:
- 1 975
- Bibliographic source:
- Journal of the Society of Cosmetic Chemistry, vol. 26, issue 1, pp. 47-63 cited in CIR (1982)
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- - Method: 7.5 cm2 clipped rat skin was exposed for 15 minutes to 0.1 mL aqueous solution containing 184 µg/mL 14C sodium stearate. The treated skin was excised after 6 hours and monitored for 14C.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium stearate
- EC Number:
- 212-490-5
- EC Name:
- Sodium stearate
- Cas Number:
- 822-16-2
- Molecular formula:
- C18H36O2.Na
- IUPAC Name:
- sodium stearate
- Test material form:
- other: Aqueous solution
- Details on test material:
- No data reported
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data reported
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- - Absorption medium: Clipped rat skin
- Absorption area: 7.5 cm2 - Duration and frequency of treatment / exposure:
- - Exposure period: 15 minutes
Doses / concentrations
- Remarks:
- Doses / Concentrations:
- Doses: 0.1 mL aqueous samples
- Concentration: 184 µg 14C sodium stearate
- No. of animals per sex per dose / concentration:
- No data reported
- Control animals:
- not specified
- Positive control reference chemical:
- No data reported
- Details on study design:
- - Method: 7.5 cm2 clipped rat skin was exposed for 15 minutes to 0.1 mL aqueous solution containing 184 µg/mL 14C sodium stearate. The treated skin was excised after 6 hours and monitored for 14C.
- Details on dosing and sampling:
- No data reported
- Statistics:
- No data reported
Results and discussion
- Preliminary studies:
- No data reported
Main ADME results
- Type:
- absorption
- Results:
- The expired CO2, urine, faeces and carcass recovered 0.53 ± 0.14 µg 14C
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Adsorption: The expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C
- Details on distribution in tissues:
- No data reported
- Details on excretion:
- No data reported
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- No data reported
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- No data reported
Applicant's summary and conclusion
- Conclusions:
- 0.1 mL aqueous solution containing 184 µg radiolabelled 14C sodium stearate was applied for 15 minutes over 7.5 cm2 of intact rat skin and the expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C.
- Executive summary:
0.1 mL aqueous solution containing 184 µg radiolabelled 14C sodium stearate was applied for 15 minutes over 7.5 cm2 of intact rat skin and the expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C. No information on the test methods used is available in the publication (CIR 1982). However, this information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
